In an innovative move to open access for Michigan cancer patients to cancer clinical trials, one MCC member, the Michigan Society of Hematology and Oncology convened a unique coalition of patient advocate groups, employers, insurance companies, and the representation of health care providers of clinical trials from both the academic and community outpatient setting to address this barrier.

In a precedent-setting agreement, all 25 members of the Michigan Association of Health Plans have agreed to work to increase participation in select cancer-related clinical trials by making payment for services within this context predictable. All member health plans are willing to provide coverage for the routine care costs of patient participation in approved clinical trials.

What the agreement does is codify the process so that providers, patients, and plans know where they stand as they make decisions regarding treatment. The document, entitled Consensus Guidelines for Healthcare Coverage of Routine Patient Care Costs Associated with Oncology Clinical Trials (Adobe Acrobat PDF file)*, details who will bear what portion of the costs of clinical cancer trials.

• Administrative costs are borne by the research cancer center.
• Expenses specifically generated by the clinical trial are covered by the pharmaceutical company.
• Costs associated with routine patient care, delivery of the investigational agent, and treatment of adverse side effects are paid by the health plans.

The consensus document also spells out the protective parameters under which this coverage will occur:

• The guidelines are applicable to Phase II and Phase III trials only.
• Only studies with potential for therapeutic benefit for patients will be considered for coverage.
• The specific trials adhere to procedural and ethical standards pertaining to conflict of interest and protection of human subjects, including peer review and review and approval by an Institutional Review Board (IRB).
• Censorship by industry sponsors is prohibited.
• The trial is being sponsored or has been approved by one or more of the following agencies: the National Institutes of Health (NIH) and NIH Cooperatives; the National Cancer Institute (NCI); the Department of Defense (DOD); the Food and Drug Administration (FDA); the Department of Veteran’s Affairs (VA); the Centers for Medicaid and Medicare; the Agency for Healthcare Research and Quality (AHRQ); the Centers for Disease Control (CDC); or a non-governmental research entity abiding by NIH guidelines.

Ad hoc investigational treatments not meeting these standards will not be covered. Clinical trials related to cancer prevention may be covered outside the scope of this agreement by individual health plans according to their individual policies and procedures.

By clearly delineating the relationship between Michigan’s managed care plans and clinical trials within the state, this innovative document — it is one of only five such documents nationwide — seeks to increase access to clinical trials and thereby improve the quality of care for its members.

This accomplishment was announced during a press conference at the Michigan State Capitol building in February 2002.

MCC Clinical Trials Action Plan presentation highlighting the creation of the Michigan Working Group to Improve Cancer Outcomes (presentated to the MCC Board of Directors, Nov. 15, 2000; available as a Microsoft PowerPoint file)**

For more information about the Michigan Working Group to Improve Cancer Outcomes, please contact Mary Malloy of the
Michigan Society of Hematology and Oncology (e-mail: malloy.msho@comcast.net).

*Please Note: You will need Adobe Acrobat Reader to open, view and print this file once it has been downloaded. If you need a free copy of Adobe Acrobat Reader, please click here.

**Please Note: You will need Microsoft PowerPoint to open, view and print this PowerPoint file once it has been downloaded. If you need a free copy of the Microsoft PowerPoint 2007 Viewer, which enables you to open, view and print full-featured presentations created in PowerPoint 97 and later versions, please click here.

Return to top of page
last updated: 08/05/07

Washington Square Building, 5th Floor · 109 Michigan Ave. · Lansing, Michigan USA 48913 Toll-Free: (877) 588-6224 · Fax: (517) 335-9397 ·